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Finite versus Indefinite Nucleos(t)ide Analogue Therapy of Patients with Chronic Hepatitis B Exhibiting Negative
Haixia Sun1, Yinhui Liu2, Yufeng Zhang1
1Department of Infectious Diseases, The Third Affiliated Hospital of Zhongshan University, No. 600 Tianhe Road, Guangzhou, 510000 Guangdong, China.
Insights
Discontinuing nucleos(t)ide analogue (NUC) therapy for chronic hepatitis B (CHB) may be safe when HBsAg levels drop below 0.05 IU/mL. Short-term consolidation therapy, less than one year, appears sufficient to prevent relapse.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Chronic hepatitis B (CHB) is a significant global health concern.
- Nucleos(t)ide analogue (NUC) therapy is a cornerstone in managing CHB.
- Assessing criteria for finite NUC therapy cessation is crucial for optimizing treatment duration and patient management.
Purpose of the Study:
- To evaluate if a serum hepatitis B surface antigen (HBsAg) level below 0.05 IU/mL can serve as a criterion for discontinuing finite NUC therapy in CHB patients.
- To compare the long-term outcomes of finite versus indefinite NUC therapy in patients achieving low HBsAg levels.
- To determine the optimal duration of consolidation therapy after achieving low HBsAg levels before NUC cessation.
Main Methods:
- Retrospective analysis of 6715 CHB patients treated between January 1998 and May 2016.
- Inclusion criteria: patients with HBsAg levels < 0.05 IU/mL.
- Comparison of outcomes between finite (n=31) and indefinite (n=40) NUC therapy groups, with subgroup analysis of consolidation therapy duration in the finite group.
Main Results:
- Baseline characteristics were similar between finite and indefinite NUC therapy groups at the time of HBsAg decline to < 0.05 IU/mL.
- No viral breakthrough or relapse occurred in any patient during a median follow-up of 120 weeks.
- Long-term outcomes showed no significant differences between finite and indefinite therapy groups, nor between short-term (<1 year) and long-term (>1 year) consolidation therapy groups.
Conclusions:
- Hepatitis B surface antigen (HBsAg) levels < 0.05 IU/mL may indicate suitability for discontinuing nucleos(t)ide analogue (NUC) therapy in chronic hepatitis B (CHB) patients.
- Consolidation therapy for less than one year appears adequate to maintain virologic control and prevent relapse after NUC cessation.
- These findings support the potential for finite NUC therapy regimens guided by HBsAg levels.
Aim:
To determine whether a decrease in HBsAg to <0.05 IU/mL could be a criterion for cessation of finite nucleos(t)ide analogue (NUC) therapy in patients with chronic hepatitis B (CHB).
Methods:
This was a retrospective analysis of 6715 patients with CHB between January 1998 and May 2016. Patients were followed up every 12-24 weeks. Among 104 patients achieving HBsAg levels < 0.05 IU/mL, 71 were eligible for inclusion in the analysis: 31 received finite NUC therapy, and 40 received indefinite NUC therapy. In the finite therapy group, 9 patients received no NUC consolidation therapy, 6 received short-term (<1 year) consolidation, and 16 received long-term (>1 year) consolidation. The outcome measures were alanine aminotransferase (ALT), total bilirubin, albumin, hepatitis B virus DNA, and HBsAg levels.
Results:
Baseline parameters and characteristics at the time when HBsAg levels had fallen to <0.05 IU/mL were similar between the finite and indefinite therapy groups. No patients experienced viral breakthrough/relapse during a median follow-up of 120 weeks. There were little or no differences in long-term outcomes between the finite and indefinite therapy groups and between the short-term and long-term consolidation groups.
Conclusions:
Discontinuation of NUCs may be acceptable in patients whose HBsAg levels fall to <0.05 IU/mL. Consolidation therapy lasting <1 year appears adequate to prevent poor long-term prognosis.
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